FDA UDI
In Commercial Distribution
🇺🇸 United States
CORE
DI: 07613327298505
·
Model: 5400052000
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CORE
- Primary DI
- 07613327298505
- Version / Model
- 5400052000
- Catalog Number
- 5400-052-000
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 196548481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-08
- Public Version
- 4
- Public Version Date
- 2019-07-05
- Public Version Status
- Update
- Public Device Record Key
- 31a32b2d-c8ec-4e6a-bb66-1f720c22534e
Device Description
2 CONSOLE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | Ear, Nose, Throat | 874.4250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41264 | Surgical power tool system control unit, line-powered | A mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327298505 | GS1 |
Customer Contacts
- Phone
- +1(800)253-3210
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity